The medical device company Distalmotion SA has hit a regulatory milestone in the commercialization of its surgical robot, Dexter, earning a CE mark in Europe.

The Dexter surgical robot is built with the aim of allowing surgeons to take a hybrid approach to minimally invasive surgery, using the robot for tasks such as suturing and complex dissections while switching to a laparoscopic approach for stapling and basic dissections.

“This unique, hybrid approach results in a substantial simplification of surgical robots and hence also a drastic reduction in robotics cost. Dexter is the surgical robot for laparoscopic surgeons,” Distalmotion CEO Michael Friedrich told BioWorld.

The regulatory clearance of the surgical robot opens to the door to market launch in Europe in 2021. Friedrich said that the company expects the hybrid approach will be a selling point for all types of hospitals, from leading university hospitals to private clinics and small, regional facilities.

“Our commercial teams have been preparing the grounds during the past two years, and we are humbled to see strong demand for Dexter, both from surgeons and nurses, as well as hospital administrators,” he said.

The Lausanne, Switzerland-based company offers a pay-per-use model, rather than a lump-sum investment, that includes fixed costs for robot rental fees and variable costs reflecting use of the company’s proprietary single-use equipment. Friedrich did not disclose specific pricing details.

Commercialization activities are focused currently on the European market, Friedrich said, but he noted that Dexter has global potential, including in the U.S. market.

Hybrid surgical approach

With the Dexter surgical robot, Distalmotion is looking to tap into the millions of medium- to high-complexity laparoscopic procedures that could be performed using a surgical robot.

Most traditional robotic surgery systems are designed to be operated in a remote, non-sterile environment, separate from the patient. This approach, Distalmotion contends, is complex and costly, limiting adoption within minimally invasive surgery. In contrast, the Dexter robot is designed to be used in a sterile environment with the surgeon moving seamlessly from the robot to the patient at the surgical table.

The Dexter robot has two surgical arms, which are used to control the robot’s two instruments. The design allows operating room teams to change trocar sites and adjust instrument positions during surgery. The lean design also allows surgeons to switch between robotic and laparoscopic processes in under 20 seconds. The surgeons can choose which tasks are best performed using the robot and which tasks should be done using traditional laparoscopic approaches. The Dexter robot is compatible with existing laparoscopic instruments and preferred imaging systems.

“In our view, the uptake of robotic systems will strongly increase with systems consciously designed for real-life clinical use, be that with regards to workflow integration, training, leveraging of existing equipment, openness to innovation as well as affordability,” Friedrich said.

In 2020, the company won a Red Dot award for the Dexter robot’s design, with competition jurors calling out the robot’s ergonomic and compact design.

The Dexter robot has been validated on human cadavers and pigs, according to the company. In August 2019, the company announced the successful completion of a cadaver study that included participation from more than 40 surgeons and nurses. The study provided a proof of concept that the robot allowed surgical tams to switch between laparoscopy and robotic surgery across a range of surgical procedures.

In early 2020, a two-phase study confirmed the system’s safety and performance. In the first phase, surgical teams across urology, gynecology, and general surgery used the Dexter robot to perform several surgical tasks, including draping, docking, suturing, dissection, switching between laparoscopy and robotics, as well as removal and emergency scenarios. In the second phase, two urologists and three general surgeons performed eight full procedures: one Nissen fundoplication, one partial cystectomy, three cholecystectomies, one radical nephrectomy, one partial gastrectomy, and one sigmoid mobilization.

“More than 60 surgical teams from Europe’s top hospitals have joined the validation studies at the various stages of the development of Dexter,” Friedrich said. “It is together with those surgeons and nurses that we have refined Dexter, which is now ready for real-life clinical use.”